Drug Approvals for April 2002

Definitions and Notes

Original New Drug Applications

Original Application #: 021310
Approval Date: 05-APR-02
Trade Name: ALORA
Chemical Type: 3
Therapeutic Potential: S
Dosage Form: PATCH, CONTROLLED RELEASE
Applicant: WATSON LABORATORIES INC
Active Ingredient(s): ESTRADIOL
OTC/RX Status: RX
Indication(s): For the prevention of postmenopausal osteoporosis for all strengths

Original Application #: 021209
Approval Date: 04-APR-02
Trade Name: SECREFLO
Chemical Type: 3
Therapeutic Potential: P
Dosage Form: INJECTABLE
Applicant: CHIRHOCLIN INC
Active Ingredient(s): SECRETIN PORCINE SYNTHETIC
OTC/RX Status: RX
Indication(s): For the use in secretin stimulation testing for stimulation of pancreatic secretions, including bicarbonate, to aid in the diagnosis of pancreatic exocrine dysfunction

Original Application #: 021136
Approval Date: 04-APR-02
Trade Name: SECREFLO
Chemical Type: 3
Therapeutic Potential: S
Dosage Form: INJECTABLE
Applicant: CHIRHOCLIN INC
Active Ingredient(s): SECRETIN PORCINE SYNTHETIC
OTC/RX Status: RX
Indication(s): For the use in secretin stimulation testing for stimulation of pancreatic secretions, including bicarbonate, to aid in the diagnosis of pancreatic exocrine dysfunction

Efficacy Supplemental New Drug Applications

Application #: 021052 Efficacy Supplement #: 007
Type: SE1 to Original New Drug Application
Approval Date: 11-APR-02
Trade Name: VIOXX
Dosage Form: SUSPENSION
Applicant: MERCK RESEARCH LABORATORIES DIV MERCK CO INC
Active Ingredient(s): ROFECOXIB
OTC/RX Status: RX
Efficacy Claim: Provide for indication of rheumatoid arthritis

Application #: 021042 Efficacy Supplement #: 012
Type: SE1 to Original New Drug Application
Approval Date: 11-APR-02
Trade Name: VIOXX
Dosage Form: TABLET
Applicant: MERCK RESEARCH LABORATORIES DIV MERCK CO INC
Active Ingredient(s): ROFECOXIB
OTC/RX Status: RX
Efficacy Claim: Provide for indication of rheumatoid arthritis

Application #: 020788 Efficacy Supplement #: 007
Type: SE8 to Original New Drug Application
Approval Date: 10-APR-02
Trade Name: PROPECIA
Dosage Form: TABLET
Applicant: MERCK & COMPANY, INC
Active Ingredient(s): FINASTERIDE
OTC/RX Status: RX
Efficacy Claim: For the treatment of male pattern hair loss (androgenetic alopecia) in MEN ONLY

Application #: 020883 Efficacy Supplement #: 004
Type: SE1 to Original New Drug Application
Approval Date: 03-APR-02
Trade Name: ARGATROBAN
Dosage Form: INJECTABLE
Applicant: TEXAS BIOTECHNOLOGY CORP
Active Ingredient(s): ARGATROBAN
OTC/RX Status: RX
Efficacy Claim:For use in patients undergoing percutaneous coronary interventions (PCI) who have or are at risk for heparin-induced thrombocytopenia

Application #: 020154 Efficacy Supplement #: 037
Type: SE8 to Original New Drug Application
Approval Date: 01-APR-02
Trade Name: VIDEX
Dosage Form: TABLET, CHEWABLE
Applicant: BRISTOL MYERS SQUIBB
Active Ingredient(s): DIDANOSINE
OTC/RX Status: RX
Efficacy Claim:For use in pediatric patients from two weeks to eight months of age

Application #: 020155 Efficacy Supplement #: 028
Type: SE8 to Original New Drug Application
Approval Date: 01-APR-02
Trade Name: VIDEX
Dosage Form: SOLUTION
Applicant: BRISTOL MYERS SQUIBB
Active Ingredient(s): DIDANOSINE
OTC/RX Status: RX
Efficacy Claim:For use in pediatric patients from two weeks to eight months of age

Application #: 020156 Efficacy Supplement #: 029
Type: SE8 to Original New Drug Application
Approval Date: 01-APR-02
Trade Name: VIDEX
Dosage Form: SOLUTION
Applicant: BRISTOL MYERS SQUIBB
Active Ingredient(s): DIDANOSINE
OTC/RX Status: RX
Efficacy Claim:For use in pediatric patients from two weeks to eight months of age

Application #: 021183 Efficacy Supplement #: 003
Type: SE8 to Original New Drug Application
Approval Date: 01-APR-02
Trade Name: VIDEX EC
Dosage Form: CAPSULE
Applicant: BRISTOL MYERS SQUIBB
Active Ingredient(s): DIDANOSINE
OTC/RX Status: RX
Efficacy Claim:For use in pediatric patients from two weeks to eight months of age

Approvable Original New Drug Applications

Original Abbreviated New Drug Applications

Original Abbreviated Application # 075984
Approval Date: 23-APR-02
Trade Name: METFORMIN HCL
Dosage Form: TABLET
Applicant: TOR PHARMACEUTICAL INC
Active Ingredient(s): METFORMIN HYDROCHLORIDE
OTC/RX Status: RX

Original Abbreviated Application # 075929
Approval Date: 22-APR-02
Trade Name: ACETAMINOPHEN, BUTALBITAL, CAFFEINE, AND CODEINE PHOSPHATE
Dosage Form: CAPSULE
Applicant: VINTAGE PHARMACEUTICALS INC
Active Ingredient(s): ACETAMINOPHEN; BUTALBITAL; CAFFEINE; CODEINE PH OSPHATE
OTC/RX Status: RX

Original Abbreviated Application # 040420
Approval Date: 19-APR-02
Trade Name: PHENTYTOIN
Dosage Form: SUSPENSION
Applicant: MORTON GROVE PHARMACEUTICALS INC
Active Ingredient(s): PHENYTOIN
OTC/RX Status: RX

Original Abbreviated Application # 040297
Approval Date: 17-APR-02
Trade Name: ESTRADIOL
Dosage Form: TABLET
Applicant: USL PHARMA INC
Active Ingredient(s): ESTRADIOL
OTC/RX Status: RX

Original Abbreviated Application # 075604
Approval Date: 10-APR-02
Trade Name: POTASSIUM CHLORIDE
Dosage Form: TABLET, EXTENDED RELEASE
Applicant: ANDRX PHARMACEUTICALS INC
Active Ingredient(s): POTASSIUM CHLORIDE
OTC/RX Status: RX

Original Abbreviated Application # 040391
Approval Date: 10-APR-02
Trade Name: HYDROXYZINE HCL
Dosage Form: SYRUP
Applicant: VINTAGE PHARMACEUTICALS INC
Active Ingredient(s): HYDROXYZINE HYDROCHLORIDE
OTC/RX Status: RX

Original Abbreviated Application # 075753
Approval Date: 09-APR-02
Trade Name: FENOFIBRATE
Dosage Form: CAPSULE
Applicant: TEVA PHARMACEUTICALS USA INC
Active Ingredient(s): FENOFIBRATE
OTC/RX Status: RX

Original Abbreviated Application # 075588
Approval Date: 08-APR-02
Trade Name: IBUPROFEN AND PSEUDOEPHEDRINE HCL
Dosage Form: TABLET
Applicant: PHARMACEUTICAL FORMULATIONS INC
Active Ingredient(s): IBUPROFEN; PSEUDOEPHEDRINE HYDROCHLORIDE
OTC/RX Status: OTC

Original Abbreviated Application # 076044
Approval Date: 05-APR-02
Trade Name: POTASSIUM CHLORIDE
Dosage Form: TABLET, EXTENDED RELEASE
Applicant: KV PHARMACEUTICAL CO
Active Ingredient(s): POTASSIUM CHLORIDE
OTC/RX Status: RX

Original Abbreviated Application # 075863
Approval Date: 05-APR-02
Trade Name: KARIVA
Dosage Form: TABLET
Applicant: BARR LABORATORIES, INC
Active Ingredient(s): DESOGESTREL; ETHINYL ESTRADIOL
OTC/RX Status: RX

Original Abbreviated Application # 075521
Approval Date: 05-APR-02
Trade Name: BUSPIRONE HCL
Dosage Form: TABLET
Applicant: TORPHARM INC
Active Ingredient(s): BUSPIRONE HYDROCHLORIDE
OTC/RX Status: RX

Original Abbreviated and 505(b)(2) New Drug Applications with Tentative Approval

Original Abbreviated Application #: 076184
Tentative Approval Date: 23-APR-02
Trade Name: ALENDRONATE SODIUM
Dosage Form: TABLET
Applicant: BARR LABORATORIES INC
Active Ingredient(s): ALENDRONATE SODIUM
OTC/RX Status: RX

Original Abbreviated Application #: 076162
Tentative Approval Date: 18-APR-02
Trade Name: METFORMIN HYDROCHLORIDE
Dosage Form: TABLET, EXTENDED RELEASE
Applicant: ANDRX PHARMACEUTICALS, INC
Active Ingredient(s): METFORMIN HYDROCHLORIDE
OTC/RX Status: RX

Labeling Supplements to Original New Drug Applications

Application #: 021119 Labeling Supplement #: 003
To Original New Drug Application
Approval Date: 30-APR-02
Trade Name: VISUDYNE
Dosage Form: INJECTABLE
Applicant: QLT INC
Active Ingredient(s): VERTEPORFIN
OTC/RX Status: RX

Application #: 017530 Labeling Supplement #: 018
To Original New Drug Application
Approval Date: 30-APR-02
Trade Name: TIGAN
Dosage Form: INJECTABLE
Applicant: KING PHARMACEUTICALS INC
Active Ingredient(s): TRIMETHOBENZAMIDE HYDROCHLORIDE
OTC/RX Status: RX

Application #: 017529 Labeling Supplement #: 009
To Original New Drug Application
Approval Date: 30-APR-02
Trade Name: TIGAN
Dosage Form: SUPPOSITORY
Applicant: KING PHARMACEUTICALS INC
Active Ingredient(s): TRIMETHOBENZAMIDE HYDROCHLORIDE
OTC/RX Status: RX

Application #: 050141 Labeling Supplement #: 219
To Original New Drug Application
Approval Date: 29-APR-02
Trade Name: BICILLIN L-A
Dosage Form: INJECTABLE
Applicant: KING PHARMACEUTICALS INC
Active Ingredient(s): PENICILLIN G BENZATHINE
OTC/RX Status: RX

Application #: 050141 Labeling Supplement #: 218
To Original New Drug Application
Approval Date: 29-APR-02
Trade Name: BICILLIN L-A
Dosage Form: INJECTABLE
Applicant: KING PHARMACEUTICALS INC
Active Ingredient(s): PENICILLIN G BENZATHINE
OTC/RX Status: RX

Application #: 050138 Labeling Supplement #: 223
To Original New Drug Application
Approval Date: 29-APR-02
Trade Name: BICILLIN C-R
Dosage Form: INJECTABLE
Applicant: KING PHARMACEUTICALS INC
Active Ingredient(s): PENICILLIN G BENZATHINE; PENICILLIN G PROCAINE
OTC/RX Status: RX

Application #: 050138 Labeling Supplement #: 222
To Original New Drug Application
Approval Date: 29-APR-02
Trade Name: BICILLIN C-R
Dosage Form: INJECTABLE
Applicant: KING PHARMACEUTICALS INC
Active Ingredient(s): PENICILLIN G BENZATHINE; PENICILLIN G PROCAINE
OTC/RX Status: RX

Application #: 018086 Labeling Supplement #: 058
To Original New Drug Application
Approval Date: 29-APR-02
Trade Name: TIMOPTIC
Dosage Form: SOLUTION, DROPS
Applicant: MERCK RESEARCH LABORATORIES DIV MERCK CO INC
Active Ingredient(s): TIMOLOL MALEATE
OTC/RX Status: RX

Application #: 020780 Labeling Supplement #: 011
To Original New Drug Application
Approval Date: 17-APR-02
Trade Name: CIPRO
Dosage Form: SUSPENSION
Applicant: BAYER CORP PHARMACEUTICAL DIV
Active Ingredient(s): CIPROFLOXACIN
OTC/RX Status: RX

Application #: 019858 Labeling Supplement #: 022
To Original New Drug Application
Approval Date: 17-APR-02
Trade Name: CIPRO IN SODIUM CHLORIDE 0.9%
Dosage Form: INJECTABLE
Applicant: BAYER CORP
Active Ingredient(s): CIPROFLOXACIN
OTC/RX Status: RX

Application #: 019857 Labeling Supplement #: 028
To Original New Drug Application
Approval Date: 17-APR-02
Trade Name: CIPRO IN DEXTROSE 5%
Dosage Form: INJECTABLE
Applicant: BAYER CORP
Active Ingredient(s): CIPROFLOXACIN
OTC/RX Status: RX

Application #: 019847 Labeling Supplement #: 026
To Original New Drug Application
Approval Date: 17-APR-02
Trade Name: CIPRO
Dosage Form: INJECTABLE
Applicant: BAYER CORP
Active Ingredient(s): CIPROFLOXACIN
OTC/RX Status: RX

Application #: 019537 Labeling Supplement #: 041
To Original New Drug Application
Approval Date: 17-APR-02
Trade Name: CIPRO
Dosage Form: TABLET
Applicant: BAYER CORP
Active Ingredient(s): CIPROFLOXACIN HYDROCHLORIDE
OTC/RX Status: RX

Application #: 019268 Labeling Supplement #: 037
To Original New Drug Application
Approval Date: 17-APR-02
Trade Name: CYTOTEC
Dosage Form: TABLET
Applicant: GD PHARMACIA CORPORATION
Active Ingredient(s): MISOPROSTOL
OTC/RX Status: RX

Application #: 018701 Labeling Supplement #: 046
To Original New Drug Application
Approval Date: 17-APR-02
Trade Name: HALDOL
Dosage Form: INJECTABLE
Applicant: R.W. JOHNSON PHARMACEUTICAL RESEARCH INSTITUTE
Active Ingredient(s): HALOPERIDOL DECANOATE
OTC/RX Status: RX

Application #: 015923 Labeling Supplement #: 072
To Original New Drug Application
Approval Date: 17-APR-02
Trade Name: HALDOL
Dosage Form: INJECTABLE
Applicant: R.W. JOHNSON PHARMACEUTICAL RESEARCH INSTITUTE
Active Ingredient(s): HALOPERIDOL LACTATE
OTC/RX Status: RX

Application #: 015922 Labeling Supplement #: 066
To Original New Drug Application
Approval Date: 17-APR-02
Trade Name: HALDOL
Dosage Form: CONCENTRATE
Applicant: R.W. JOHNSON PHARMACEUTICAL RESEARCH INSTITUTE
Active Ingredient(s): HALOPERIDOL LACTATE
OTC/RX Status: RX

Application #: 015921 Labeling Supplement #: 076
To Original New Drug Application
Approval Date: 17-APR-02
Trade Name: HALDOL
Dosage Form: TABLET
Applicant: R.W. JOHNSON PHARMACEUTICAL RESEARCH INSTITUTE
Active Ingredient(s): HALOPERIDOL
OTC/RX Status: RX

Application #: 011340 Labeling Supplement #: 016
To Original New Drug Application
Approval Date: 17-APR-02
Trade Name: CERUMENEX
Dosage Form: SOLUTION
Applicant: PURDUE FREDERICK CO
Active Ingredient(s): TRIETHANOLAMINE POLYPEPTIDE OLEATE CONDENSATE
OTC/RX Status: OTC

Application #: 010596 Labeling Supplement #: 017
To Original New Drug Application
Approval Date: 17-APR-02
Trade Name: CELONTIN
Dosage Form: CAPSULE
Applicant: PARKE DAVIS DIV WARNER LAMBERT CO
Active Ingredient(s): METHSUXIMIDE
OTC/RX Status: RX

Application #: 019958 Labeling Supplement #: 013
To Original New Drug Application
Approval Date: 16-APR-02
Trade Name: CUTIVATE
Dosage Form: EMULSION, CREAM
Applicant: GLAXOSMITHKLINE
Active Ingredient(s): FLUTICASONE PROPIONATE
OTC/RX Status: RX

Application #: 020496 Labeling Supplement #: 007
To Original New Drug Application
Approval Date: 15-APR-02
Trade Name: AMARYL
Dosage Form: TABLET
Applicant: AVENTIS PHARMACEUTICALS INC
Active Ingredient(s): GLIMEPIRIDE
OTC/RX Status: RX

Application #: 020182 Labeling Supplement #: 008
To Original New Drug Application
Approval Date: 15-APR-02
Trade Name: CARNITOR
Dosage Form: INJECTABLE
Applicant: SIGMA TAU PHARMACEUTICALS INC
Active Ingredient(s): LEVOCARNITINE
OTC/RX Status: RX

Application #: 019257 Labeling Supplement #: 010
To Original New Drug Application
Approval Date: 15-APR-02
Trade Name: CARNITOR
Dosage Form: SOLUTION
Applicant: SIGMA TAU PHARMACEUTICALS INC
Active Ingredient(s): LEVOCARNITINE
OTC/RX Status: RX

Application #: 018948 Labeling Supplement #: 022
To Original New Drug Application
Approval Date: 15-APR-02
Trade Name: CARNITOR
Dosage Form: TABLET
Applicant: SIGMA TAU PHARMACEUTICALS INC
Active Ingredient(s): LEVOCARNITINE
OTC/RX Status: RX

Application #: 020408 Labeling Supplement #: 023
To Original New Drug Application
Approval Date: 12-APR-02
Trade Name: TRUSOPT
Dosage Form: SOLUTION, DROPS
Applicant: MERCK RESEARCH LABORATORIES DIV MERCK CO INC
Active Ingredient(s): DORZOLAMIDE HYDROCHLORIDE
OTC/RX Status: RX

Application #: 018662 Labeling Supplement #: 047
To Original New Drug Application
Approval Date: 12-APR-02
Trade Name: ACCUTANE
Dosage Form: CAPSULE
Applicant: HLR TECHNOLOGY
Active Ingredient(s): ISOTRETINOIN
OTC/RX Status: RX

Application #: 050672 Labeling Supplement #: 018
To Original New Drug Application
Approval Date: 11-APR-02
Trade Name: CEFTIN
Dosage Form: SUSPENSION
Applicant: GLAXOSMITHKLINE
Active Ingredient(s): CEFUROXIME AXETIL
OTC/RX Status: RX

Application #: 050605 Labeling Supplement #: 033
To Original New Drug Application
Approval Date: 11-APR-02
Trade Name: CEFTIN
Dosage Form: TABLET
Applicant: GLAXOSMITHKLINE
Active Ingredient(s): CEFUROXIME AXETIL
OTC/RX Status: RX

Application #: 021052 Labeling Supplement #: 009
To Original New Drug Application
Approval Date: 11-APR-02
Trade Name: VIOXX
Dosage Form: SUSPENSION
Applicant: MERCK RESEARCH LABORATORIES DIV MERCK CO INC
Active Ingredient(s): ROFECOXIB
OTC/RX Status: RX

Application #: 021052 Labeling Supplement #: 008
To Original New Drug Application
Approval Date: 11-APR-02
Trade Name: VIOXX
Dosage Form: SUSPENSION
Applicant: MERCK RESEARCH LABORATORIES DIV MERCK CO INC
Active Ingredient(s): ROFECOXIB
OTC/RX Status: RX

Application #: 021052 Labeling Supplement #: 006
To Original New Drug Application
Approval Date: 11-APR-02
Trade Name: VIOXX
Dosage Form: SUSPENSION
Applicant: MERCK RESEARCH LABORATORIES DIV MERCK CO INC
Active Ingredient(s): ROFECOXIB
OTC/RX Status: RX

Application #: 021052 Labeling Supplement #: 005
To Original New Drug Application
Approval Date: 11-APR-02
Trade Name: VIOXX
Dosage Form: SUSPENSION
Applicant: MERCK RESEARCH LABORATORIES DIV MERCK CO INC
Active Ingredient(s): ROFECOXIB
OTC/RX Status: RX

Application #: 021042 Labeling Supplement #: 014
To Original New Drug Application
Approval Date: 11-APR-02
Trade Name: VIOXX
Dosage Form: TABLET
Applicant: MERCK RESEARCH LABORATORIES DIV MERCK CO INC
Active Ingredient(s): ROFECOXIB
OTC/RX Status: RX

Application #: 021042 Labeling Supplement #: 013
To Original New Drug Application
Approval Date: 11-APR-02
Trade Name: VIOXX
Dosage Form: TABLET
Applicant: MERCK RESEARCH LABORATORIES DIV MERCK CO INC
Active Ingredient(s): ROFECOXIB
OTC/RX Status: RX

Application #: 021042 Labeling Supplement #: 010
To Original New Drug Application
Approval Date: 11-APR-02
Trade Name: VIOXX
Dosage Form: TABLET
Applicant: MERCK RESEARCH LABORATORIES DIV MERCK CO INC
Active Ingredient(s): ROFECOXIB
OTC/RX Status: RX

Application #: 021042 Labeling Supplement #: 008
To Original New Drug Application
Approval Date: 11-APR-02
Trade Name: VIOXX
Dosage Form: TABLET
Applicant: MERCK RESEARCH LABORATORIES DIV MERCK CO INC
Active Ingredient(s): ROFECOXIB
OTC/RX Status: RX

Application #: 020083 Labeling Supplement #: 029
To Original New Drug Application
Approval Date: 11-APR-02
Trade Name: SPORANOX
Dosage Form: CAPSULE
Applicant: JANSSEN RESEARCH FDN DIV JOHNSON AND JOHNSON
Active Ingredient(s): ITRACONAZOLE
OTC/RX Status: RX

Application #: 050754 Labeling Supplement #: 001
To Original New Drug Application
Approval Date: 10-APR-02
Trade Name: AMOXIL
Dosage Form: TABLET
Applicant: GLAXOSMITHKLINE
Active Ingredient(s): AMOXICILLIN
OTC/RX Status: RX

Application #: 050726 Labeling Supplement #: 004
To Original New Drug Application
Approval Date: 10-APR-02
Trade Name: AUGMENTIN '200'
Dosage Form: TABLET, CHEWABLE
Applicant: GLAXOSMITHKLINE
Active Ingredient(s): AMOXICILLIN; CLAVULANATE POTASSIUM
OTC/RX Status: RX

Application #: 050725 Labeling Supplement #: 004
To Original New Drug Application
Approval Date: 10-APR-02
Trade Name: AUGMENTIN '200'
Dosage Form: SUSPENSION
Applicant: GLAXOSMITHKLINE
Active Ingredient(s): AMOXICILLIN; CLAVULANATE POTASSIUM
OTC/RX Status: RX

Application #: 050720 Labeling Supplement #: 006
To Original New Drug Application
Approval Date: 10-APR-02
Trade Name: AUGMENTIN '875'
Dosage Form: TABLET
Applicant: GLAXOSMITHKLINE
Active Ingredient(s): AMOXICILLIN; CLAVULANATE POTASSIUM
OTC/RX Status: RX

Application #: 050597 Labeling Supplement #: 030
To Original New Drug Application
Approval Date: 10-APR-02
Trade Name: AUGMENTIN '125'
Dosage Form: TABLET, CHEWABLE
Applicant: GLAXOSMITHKLINE
Active Ingredient(s): AMOXICILLIN; CLAVULANATE POTASSIUM
OTC/RX Status: RX

Application #: 050575 Labeling Supplement #: 025
To Original New Drug Application
Approval Date: 10-APR-02
Trade Name: AUGMENTIN '125'
Dosage Form: SUSPENSION
Applicant: GLAXOSMITHKLINE
Active Ingredient(s): AMOXICILLIN; CLAVULANATE POTASSIUM
OTC/RX Status: RX

Application #: 050564 Labeling Supplement #: 034
To Original New Drug Application
Approval Date: 10-APR-02
Trade Name: AUGMENTIN '250'
Dosage Form: TABLET
Applicant: GLAXOSMITHKLINE
Active Ingredient(s): AMOXICILLIN; CLAVULANATE POTASSIUM
OTC/RX Status: RX

Application #: 050542 Labeling Supplement #: 016
To Original New Drug Application
Approval Date: 10-APR-02
Trade Name: AMOXIL
Dosage Form: TABLET, CHEWABLE
Applicant: GLAXOSMITHKLINE
Active Ingredient(s): AMOXICILLIN
OTC/RX Status: RX

Application #: 020788 Labeling Supplement #: 005
To Original New Drug Application
Approval Date: 10-APR-02
Trade Name: PROPECIA
Dosage Form: TABLET
Applicant: MERCK RESEARCH LABORATORIES DIV MERCK CO INC
Active Ingredient(s): FINASTERIDE
OTC/RX Status: RX

Application #: 020788 Labeling Supplement #: 004
To Original New Drug Application
Approval Date: 10-APR-02
Trade Name: PROPECIA
Dosage Form: TABLET
Applicant: MERCK RESEARCH LABORATORIES DIV MERCK CO INC
Active Ingredient(s): FINASTERIDE
OTC/RX Status: RX

Application #: 021259 Labeling Supplement #: 001
To Original New Drug Application
Approval Date: 09-APR-02
Trade Name: METADATE CD
Dosage Form: CAPSULE, EXTENDED RELEASE
Applicant: CELLTECH PHARMACEUTICALS INC
Active Ingredient(s): METHYLPHENIDATE HYDROCHLORIDE
OTC/RX Status: RX

Application #: 021246 Labeling Supplement #: 007
To Original New Drug Application
Approval Date: 09-APR-02
Trade Name: TAMIFLU
Dosage Form: SUSPENSION
Applicant: HOFFMANN LA ROCHE INC
Active Ingredient(s): OSELTAMIVIR PHOSPHATE
OTC/RX Status: RX

Application #: 021087 Labeling Supplement #: 010
To Original New Drug Application
Approval Date: 09-APR-02
Trade Name: TAMIFLU
Dosage Form: CAPSULE
Applicant: HOFFMANN LA ROCHE INC
Active Ingredient(s): OSELTAMIVIR PHOSPHATE
OTC/RX Status: RX

Application #: 020408 Labeling Supplement #: 025
To Original New Drug Application
Approval Date: 09-APR-02
Trade Name: TRUSOPT
Dosage Form: SOLUTION, DROPS
Applicant: MERCK RESEARCH LABORATORIES DIV MERCK CO INC
Active Ingredient(s): DORZOLAMIDE HYDROCHLORIDE
OTC/RX Status: RX

Application #: 020264 Labeling Supplement #: 009
To Original New Drug Application
Approval Date: 09-APR-02
Trade Name: MEGACE
Dosage Form: SUSPENSION
Applicant: BRISTOL MYERS SQUIBB
Active Ingredient(s): MEGESTROL ACETATE
OTC/RX Status: RX

Application #: 020655 Labeling Supplement #: 008
To Original New Drug Application
Approval Date: 05-APR-02
Trade Name: ALORA
Dosage Form: FILM, CONTROLLED RELEASE
Applicant: WATSON LABORATORIES INC
Active Ingredient(s): ESTRADIOL
OTC/RX Status: RX

Application #: 019047 Labeling Supplement #: 018
To Original New Drug Application
Approval Date: 03-APR-02
Trade Name: PLASMA-LYTE 56 IN PLASTIC CONTAINER
Dosage Form: INJECTABLE
Applicant: BAXTER HEALTHCARE CORP
Active Ingredient(s): SODIUM CHLORIDE; POTASSIUM ACETATE; MAGNESIUM ACETATE TETRAHYDRATE
OTC/RX Status: RX

Application #: 019022 Labeling Supplement #: 017
To Original New Drug Application
Approval Date: 03-APR-02
Trade Name: SODIUM CHLORIDE 3% IN PLASTIC CONTAINER
Dosage Form: INJECTABLE
Applicant: BAXTER HEALTHCARE CORP
Active Ingredient(s): SODIUM CHLORIDE
OTC/RX Status: RX

Application #: 018016 Labeling Supplement #: 049
To Original New Drug Application
Approval Date: 03-APR-02
Trade Name: SODIUM CHLORIDE 0.45%
Dosage Form: INJECTABLE
Applicant: BAXTER HEALTHCARE CORP
Active Ingredient(s): SODIUM CHLORIDE
OTC/RX Status: RX

Application #: 017438 Labeling Supplement #: 051
To Original New Drug Application
Approval Date: 03-APR-02
Trade Name: PLASMA-LYTE R IN PLASTIC CONTAINER
Dosage Form: INJECTABLE
Applicant: BAXTER HEALTHCARE CORP
Active Ingredient(s): SODIUM ACETATE; SODIUM CHLORIDE; SODIUM LACTATE ; POTASSIUM CHLORIDE; CALCIUM CHLORIDE; MAGNESIUM CHLORIDE
OTC/RX Status: RX

Application #: 017378 Labeling Supplement #: 055
To Original New Drug Application
Approval Date: 03-APR-02
Trade Name: PLASMA-LYTE 148 IN WATER IN PLASTIC CONTAINER
Dosage Form: INJECTABLE
Applicant: BAXTER HEALTHCARE CORP
Active Ingredient(s): SODIUM CHLORIDE; SODIUM ACETATE; SODIUM GLUCONA TE; POTASSIUM CHLORIDE; MAGNESIUM CHLORIDE
OTC/RX Status: RX

Application #: 016693 Labeling Supplement #: 084
To Original New Drug Application
Approval Date: 03-APR-02
Trade Name: RINGER'S IN PLASTIC CONTAINER
Dosage Form: INJECTABLE
Applicant: BAXTER HEALTHCARE CORP
Active Ingredient(s): POTASSIUM CHLORIDE; SODIUM CHLORIDE; CALCIUM CH LORIDE
OTC/RX Status: RX

Application #: 016682 Labeling Supplement #: 092
To Original New Drug Application
Approval Date: 03-APR-02
Trade Name: LACTATED RINGER'S IN PLASTIC CONTAINER
Dosage Form: INJECTABLE
Applicant: BAXTER HEALTHCARE CORP
Active Ingredient(s): SODIUM LACTATE; SODIUM CHLORIDE; POTASSIUM CHLO RIDE; CALCIUM CHLORIDE
OTC/RX Status: RX

Application #: 016677 Labeling Supplement #: 124
To Original New Drug Application
Approval Date: 03-APR-02
Trade Name: SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
Dosage Form: INJECTABLE
Applicant: BAXTER HEALTHCARE CORP
Active Ingredient(s): SODIUM CHLORIDE
OTC/RX Status: RX

Application #: 021343 Labeling Supplement #: 001
To Original New Drug Application
Approval Date: 01-APR-02
Trade Name: ELIGARD
Dosage Form: INJECTABLE
Applicant: SANOFI-SYTHELABO, INC
Active Ingredient(s): LEUPROLIDE ACETATE
OTC/RX Status: RX

Application #: 021285 Labeling Supplement #: 002
To Original New Drug Application
Approval Date: 01-APR-02
Trade Name: TRILEPTAL
Dosage Form: SUSPENSION
Applicant: NOVARTIS PHARMACEUTICALS CORP
Active Ingredient(s): OXCARBAZEPINE
OTC/RX Status: RX

Application #: 021014 Labeling Supplement #: 006
To Original New Drug Application
Approval Date: 01-APR-02
Trade Name: TRILEPTAL
Dosage Form: TABLET
Applicant: NOVARTIS PHARMACEUTICALS CORP
Active Ingredient(s): OXCARBAZEPINE
OTC/RX Status: RX

Definitions

Approvable Original New Drug Applications

An approvable letter indicates that FDA is prepared to approve the application upon the satisfaction of conditions specified in the approvable letter. Drug products which are the subject of approvable letters may not be legally marketed until the firm has satisfied the identified deficiencies, as well as any other requirements that may be imposed by FDA, and has been notified in writing that the application has been approved. Further information on approvable NDAs is not subject to Freedom of Information (FOI) release until applications are approved.

Original Abbreviated and 505(b)(2) New Drug Applications with Tentative Approval

A tentative approval indicates that FDA has given an abbreviated new drug application (ANDA) or 505(b)(2) application provisional approval under the terms of the Drug Price Competition and Patent Term Restoration Act. Such drug products that are the subjects of tentative approvals may not be legally marketed until the market exclusivity and/or patent term of the listed reference drug product has expired. Final approval is also contingent upon conditions and information available to FDA remaining acceptable. When the application receives final approval, the product may be legally marketed. The effective approval date will be listed in this publication and in the " Approved Drug Products with Therapeutic Equivalence Evaluations" list published by FDA. Additional information on these applications will become available to the public when the applications receive final approval. Notes

Notes:

FDA classifies investigational new drug applications (INDs) and new drug applications (NDAs) to assign review priority on the basis of the drug's chemical type and potential benefit:

Chemical Type (CHE)

1. New molecular entity, or NME: An active ingredient that has never been marketed in this country.

2. New derivative: A chemical derived from an active ingredient already marketed (a "parent" drug).

3. New formulation: A new dosageform or new formulation of an active ingredient already on the market.

4. New combination: A drug that contains two or more compounds, the combination of which has not been marketed together in a product.

5. Already marketed drug product but a new manufacturer: A product that duplicates another firm's already marketed drug product: same active ingredient, formulation, or combination.

6. Already marketed drug product, but a new use: A new use for a drug product already marketed by a different firm.

7. Drug already legally marketed without an approved NDA

1 - First post-1962 applications for products marketed prior to 1938
2 - First applications for DESI-related products first marketed between 1938 and 1962 without NDAs
3 - First applications for DESI-related products first marketed after 1962 without NDAs - The indications can be the same or different from the legally marketed product

Effectiveness Supplement Code Definitions

SE1 A new indication or a significant modification of an existing indication, including removal of a major limitation to use, such as second line status.

SE2 A new dosage regimen, including an increase or decrease in daily dosage, or a change in frequency of administration.

SE3 A new route of administration.

SE4 A comparative efficacy claim naming another drug, including a comparative pharmacokinetic claim.

SE5 A change in sections other than the INDICATIONS AND USAGE section that would significantly alter the patient population to be treated, such as addition of pediatric use and/or dosing information or geriatric use and/or dosing information.

SE6 An Rx-to-OTC switch.

SE7 Supplement-Accelerated Approval

SE8 Efficacy Supplement with Clinical Data to Support Labeling Claim

Treatment Potential (TP)

P-Priority review drug: A drug that appears to represent an advance over available therapy

S-Standard review drug: A drug that appears to have therapeutic qualities similar to those of an already marketed drug.

Other Designations (may apply simultaneously)

AA AIDS drug: A drug indicated for treating AIDS or other HIV related disease.

E Subpart E drug: A drug developed or evaluated under special procedures for drugs to treat lifethreatening or severely debilitating illnesses. (The name refers to Title 21 of the Code of Federal Regulations, Part 312, Subpart E, which governs this classification. Also see, "The Evolution of U.S. Drug Law," page 26 of the booklet, From Test Tube to Patient: NEW DRUG DEVELOPMENT IN THE UNITED STATES.)

V Designated orphan drug: A drug for which the sponsor received orphan designation under the Orphan Drug Act. Such a sponsor is eligible for tax credits and exclusive marketing rights for the drug.